Back to resultsPhase I Trial of Periocular Topotecan in Retinoblastoma
Primary Purpose
Retinoblastoma
Status
Completed
Phase
Phase 1
Locations
Argentina
Study Type
Interventional
Intervention
Topotecan
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring topotecan, periocular, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Group Vb (Reese Ellsworth)
- Relapsed or progressed after carboplatin-based regimens and external beam radiotherapy
- Enucleation of the contralateral eye
- Normal renal and liver function
Exclusion Criteria:
- Presence of glaucoma, rubeosis iridis, anterior chamber extension
- Extraocular disease
- Adequate follow up impossible for social reasons
Sites / Locations
- Hospital JP Garrahan
Outcomes
Primary Outcome Measures
Dose limiting toxicity
Secondary Outcome Measures
Response rate, description of toxicity, pharmacokinetic profile
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00460876
Brief Title
Phase I Trial of Periocular Topotecan in Retinoblastoma
Official Title
Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital JP Garrahan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.
Detailed Description
Patients with bilateral retinoblastoma who have relapsed after attempts of conservative therapy with standard regimens such as carboplatin, etoposide, vincristine and external beam radiotherapy who face immediate enucleation of their single remaining eye are eligible for this protocol. Starting dose of topotecan will be 0.5 mg and dose escalation will be done by the accelerated titration method. Any Grade 3 ocular toxicity or grade 4 non ocular toxicity will be designed as the dose limiting toxicity. Grade 2 scleral toxicity will be considered for DLT. In case of grade 2 ocular toxicity or grade 3 systemic toxicity, the escalation dose will be 0.25 mg. Maximal dose will be 2 mg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
topotecan, periocular, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topotecan
Primary Outcome Measure Information:
Title
Dose limiting toxicity
Secondary Outcome Measure Information:
Title
Response rate, description of toxicity, pharmacokinetic profile
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Group Vb (Reese Ellsworth)
Relapsed or progressed after carboplatin-based regimens and external beam radiotherapy
Enucleation of the contralateral eye
Normal renal and liver function
Exclusion Criteria:
Presence of glaucoma, rubeosis iridis, anterior chamber extension
Extraocular disease
Adequate follow up impossible for social reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo L Chantada, MD
Organizational Affiliation
Hospital JP Garrahan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital JP Garrahan
City
Buenos Aires
State/Province
CF
ZIP/Postal Code
C1245AAL
Country
Argentina
12. IPD Sharing Statement
Citations:
PubMed Identifier
18978345
Citation
Chantada GL, Fandino AC, Carcaboso AM, Lagomarsino E, de Davila MT, Guitter MR, Rose AB, Manzitti J, Bramuglia GF, Abramson DH. A phase I study of periocular topotecan in children with intraocular retinoblastoma. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1492-6. doi: 10.1167/iovs.08-2737. Epub 2008 Oct 31.
Results Reference
derived
Learn more about this trial
Phase I Trial of Periocular Topotecan in Retinoblastoma
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